Healthcare
Nuvation Bio Announces Marketing Authorisation Application for Taletrectinib for the Treatment of Advanced ROS1-Positive Non-Small Cell Lung Cancer Validated in the United Kingdom
Nuvation Bio (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (U.K.) has validated the Marketing Authorisation Application (MAA) submitted by its partner Eisai Co, Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai"), for taletrectinib for the treatment of advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC). The a
About this update from Nuvation Bio Inc.
FOR U.S. AUDIENCES ONLY. THIS PRESS RELEASE IS NOT FOR A U.K. AUDIENCE. A Marketing Authorisation Application with the European Medicines Agency is also under regulatory review for approval NEW YORK, June 29, 2026 /PRNewswire/ -- Nuvation Bio (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (U.K.) has validated the Marketing Authorisation Application (MAA) submitted by its partner Eisai Co, Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai"), for taletrectinib for the treatment of advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC). The application was submitted through the International Recognition Procedure, which takes into account approvals from trusted regulatory partners and supports expedited access to medicines in the U.K. The application will now be evaluated by the MHRA to decide whether to approve or reject the application. In January 2026, Eisai and Nuvation Bio announced they had entered into an exclusive licensing and collaboration agreement in Europe and additional countries* outside the U.S., China and Japan to extend the global reach of taletrectinib. Taletrectinib is an oral treatment for patients living with advanced ROS1+ NSCLC (marketed as IBTROZI® in the U.S. and Japan). In March 2026, the European Medicines Agency validated the MAA for taletrectinib. Additional filings are planned for Canada and other regions included in Eisai's licensed territories. Within the U.K., there are around 50,200 new lung cancer cases every year. Around 80 to 85% of all lung cancers are NSCLC, of which approximately 2% of patients harbor the ROS1+ mutation. The application is based on data from the two pivotal Phase 2 clinical studies, TRUST-I and TRUST-II, evaluating taletrectinib in patients globally. Results from a pooled analysis of the TRUST clinical program were originally published in the Journal of Clinical Oncology in April 2025, and updated data reflecting longer patient follow-up were presented at the American Association for Cancer Research (AACR) Annual Meeting in April 2026, further building the efficacy and safety profile observed to date. Updated results from the TRUST-I study were also simultaneously published in April 2026 in the Journal of Clinical ...